Medical Article Securement Systems

ABSTRACT

A medical article, such as a catheter, is secured with respect to a patient with a securement device. The securement device may include a retainer and anchor pad. Certain devices may further include, for example, straps, flaps, dressings, slots, and recesses for securing the medical article to the patient. The retainer may include a recess and/or a channel. At least one surface of the retainer may be coated with an adhesive. A support member may be coupled to the retainer. The support member may include a channel configured to receive a proximally extending portion of the medical article.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of International ApplicationNo. PCT/US2013/058606, filed Sep. 6, 2013, titled “MEDICAL ARTICLESECUREMENT SYSTEMS,” which claims priority under 35 U.S.C. §119(e) toU.S. Provisional Application No. 61/698,251, filed Sep. 7, 2012, titled“MEDICAL ARTICLE SECUREMENT SYSTEMS,” and to U.S. ProvisionalApplication No. 61/868,778, filed Aug. 22, 2013, titled “MEDICAL ARTICLESECUREMENT SYSTEMS,” each of which is hereby incorporated by referencein its entirety into this application.

BACKGROUND

1. Field

The present invention relates generally to techniques, systems, anddevices for securing a catheter, catheter extension set, and/or othermedical article to a patient.

2. Description of the Related Art

Medical patients are often in need of repetitious administering offluids or medications, or repetitious draining of fluids. It is verycommon in the medical industry to utilize medical tubing to providevarious liquids or solutions to a patient. For example, medical tubingsuch as a catheter is often used to introduce fluids and medicationsdirectly into the patient or to withdraw fluids from the patient. Inmany cases, the catheter remains in place for many days. In someinstances, a catheter may be attached to a patient for an even lengthierperiod of time, and may require minimal movement for proper functioning.

It is often advantageous to restrict the movement of the catheter. Amoving catheter may cause discomfort to the patient, restrict theadministering of fluids or medications or the draining of fluids, causeinfection, or become dislodged from the patient unintentionally. Inorder to keep the catheter or other medical tubing properly positionedfor the duration of treatment, the catheter or medical tubing can bestabilized on the patient in a variety of ways. Most commonly, themedical provider may attempt to restrict movement of the catheter bysecuring the distal end of the catheter, or a portion of a medicaldevice connected to the catheter such as a connector fitting, to thepatient using tape. Medical providers commonly place long pieces of tapeacross the distal end of the catheter, often in a crisscross pattern, tosecure the catheter distal end to the patient. This securement isintended to inhibit disconnection between the catheter and the patientor between the catheter and another medical article, such as a drainagetube, as well as to prevent the catheter from catching on other objects,such as on a bed rail.

SUMMARY OF THE INVENTIONS

The devices, systems, and methods of the present disclosure have severalfeatures, no single one of which is solely responsible for its desirableattributes. Without limiting the scope of this invention as expressed bythe claims which follow, its more prominent features will now bediscussed briefly. After considering this discussion, and particularlyafter reading the section entitled “Detailed Description of CertainEmbodiments,” one will understand how the features of this disclosureprovide several advantages over other securement systems.

One aspect is a securement system comprising a medical article having anelongated body and a stabilization device having a retainer and ananchor pad. The retainer may have a proximal side, a distal side, and anupper side. The retainer may have a recess and a channel disposed withinthe retainer. The channel may extend from the recess to the proximalside of the retainer. At least a portion of the elongated body may bedisposed within the recess. At least a portion of the elongated body mayextend through the channel and beyond the proximal side of the retainer.The retainer may include at least one adhesive surface. The adhesivesurface may be disposed on at least a portion of an upwardly facingsurface of the retainer. The channel may have a lateral width less thana lateral width of the recess. The retainer may include at least oneabutment configured to contact a proximal facing surface of theelongated body to prevent the elongated body from moving in at least theproximal direction. The at least one abutment may be disposed betweenthe recess and the channel. The abutment may be configured to contact adistal facing surface of the elongated body to prevent the elongatedbody from moving in at least a distal direction.

Another aspect is a retainer configured to secure a medical articlehaving an elongated body. The retainer may comprise a proximal side, adistal side, a bottom side, and a top side. A recess may be disposed inthe top side of the retainer. The recess may be configured to receive afirst portion of the elongated body. A channel may extend from therecess through the proximal side of the retainer. The channel may beconfigured to receive a second portion of the elongated body. An anchorpad may be secured to the bottom side of the retainer and configured tosecure the anchor pad to the skin of a patient. The channel may have alateral width less than a lateral width of the recess.

Another aspect is a securement system comprising a medical articlehaving an elongated body and a stabilization device. The device includesa retainer and an anchor pad. The retainer includes a recess and a flapwith the flap being movable from an open position to a closed position.At least a portion of the body is disposed in the recess and below theflap to secure the body to the retainer at least when the flap is in theclosed position.

Another aspect is a securement system comprising a medical articlehaving an elongated body and a stabilization device. The device includesa retainer and an anchor pad. The retainer includes a recess and adressing with the dressing being movable from an open position to aclosed position. At least a portion of the body is disposed in therecess and below the dressing to secure the body to the retainer atleast when the dressing is in the closed position.

Another aspect is a securement system comprising a medical articlehaving an elongated body and a stabilization device. The device includesa retainer and an anchor pad. The retainer includes a recess forreceiving at least a portion of the medical article. A first portion ofthe anchor pad is movable from an open position to a closed positionwith the first portion adhering to a second portion of the anchor padwhen in the closed position.

Another aspect is a securement system comprising a medical articlehaving an elongated body and a stabilization device. The device includesa retainer and an anchor pad. The retainer is supported by the anchorpad and configured to receive the medical article. The system furtherincludes a dressing connected to the anchor pad and being configured tocover an insertion site. The dressing has a lower surface at leastpartially covered by an adhesive for contacting the patient's skin and aslot configured to allow the medical article to pass between at least aportion of the anchor pad and the dressing during application of thedressing to the patient's skin.

Another aspect is a securement system comprising a medical articlehaving an elongated body and a stabilization device. The stabilizationdevice may have a retainer and an anchor pad. The retainer may have aproximal side, a distal side, and an upper side. The retainer mayinclude at least one adhesive surface. In some aspects, the upper sideof the retainer includes at least one adhesive surface. The retainer mayhave a recess and a channel formed within the retainer. The channel mayextend from the recess to the proximal side of the retainer. At least aportion of the elongated body may be disposed within the recess and thechannel. At least a portion of the elongated body may contact the atleast one adhesive surface of the retainer.

Another aspect is a securement system also has a dressing having a padlayer and a transparent film layer. The pad may have a first window sothat the body of the medical article is visible through the first windowwhen the dressing is placed over the stabilization device. The pad mayinclude a second window so that the insertion site of the medicalarticle is visible through the second window when the dressing is placedover the stabilization device. In some aspects, the recess includes atleast one abutment configured to contact a proximal facing surface ofthe elongated body to prevent the body from moving in at least theproximal direction.

Another aspect is a securement device configured to secure a medicalarticle having an elongated body to a patient that may comprise ananchor pad and a retainer supported by the anchor pad. The retainer maycomprise a recess configured to receive at least a portion of theelongated body. A dressing may be coupled to the anchor pad. Thedressing may be configured to be movable from an open position to aclosed position to secure the elongated body to the retainer and tocover an insertion site at least when the dressing is in the closedposition.

Another aspect is a securement device configured to secure a medicalarticle having an elongated body to a patient that may comprise ananchor pad and a retainer supported by the anchor pad. The retainer maycomprise a recess configured to receive at least a portion of theelongated body. A flap may be coupled to the anchor pad. The flap may beconfigured to be movable from an open position to a closed position. Theflap may include at least one adhesive surface configured to secure theflap to at least the elongated body when the flap is in the closedposition.

Another aspect is a securement device configured to secure a medicalarticle having an elongated body to a patient that may comprise ananchor pad having a first portion and a second portion. The firstportion of the anchor pad may be configured to be movable from an openposition to a closed position and may be configured to adhere to thesecond portion of the anchor pad when the first portion of the anchorpad in the closed position. A retainer may be supported by the secondportion of the anchor pad. The retainer may comprise a recess configuredto receive at least a portion of the medical article.

Another aspect is a securement device configured to secure a medicalarticle having an elongated body to a patient that may comprise ananchor pad and a retainer supported by the anchor pad. The retainer maybe configured to receive at least a portion of the medical article. Adressing may be connected to the anchor pad. The dressing may beconfigured to cover an insertion site. The dressing may have a lowersurface at least partially covered by an adhesive for adhering thedressing to the skin of a patient. The dressing may have a slotconfigured to allow the medical article to pass between at least aportion of the anchor pad and the dressing during application of thedressing and the anchor pad to the skin of the patient.

Another aspect is a securement device configured to secure a medicalarticle having an elongated body to a patient that may comprise ananchor pad and a retainer supported by the anchor pad. The retainer maybe configured to receive at least a portion of the medical article. Asupport member may be coupled to the anchor pad, the support memberconfigured to support a portion of the medical article extendingdistally of a recess in the retainer. The support member may include apassage for releasably locking the support member to the medicalarticle. The support member may be formed in the shape of a prism. Thesupport member may be coupled to the retainer along a fold line. Thefold line may be perforated to facilitate separation of the supportmember from the retainer.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features, aspects, and advantages of the inventiondisclosed herein are described below with reference to the drawings ofcertain embodiments, which are intended to illustrate and not to limitthe invention. Additionally, from figure to figure, the same referencenumerals have been used to designate the same components of anillustrated embodiment. The following is a brief description of each ofthe drawings.

FIGS. 1-2 are perspective views of a securement device according to anembodiment of the present invention.

FIGS. 3-4 are perspective views of the securement device of FIG. 1 withthe liners removed.

FIG. 5 is an exploded view of the securement device of FIG. 2.

FIG. 6 is a plan view of the securement device of FIG. 1 with the linersremoved.

FIG. 7 is a perspective view of the securement device of FIG. 3 with theliners removed and a medical article placed in the retainer.

FIGS. 8-9 are perspective views of a dressing that may be used incombination with the securement device of FIG. 1.

FIG. 10 is an exploded view of the dressing of FIG. 8.

FIG. 11 is a plan view of the dressing of FIG. 8.

FIGS. 12A and 13-14 are perspective views of a method of using thesecurement device of FIG. 1. As shown, the method can begin by removinga liner disposed over the retainer.

FIGS. 12B-D are perspective views of liners for disposal over a surfaceof the retainer or anchor pad.

FIGS. 15-17 are perspective views of a method of using the securementdevice of FIG. 1. As shown, the method can continue by removing a firstliner disposed over a portion of the bottom surface of the retainer. Theretainer may be placed on a patient and a medical article may be placedin the retainer.

FIGS. 18-19 are perspective views of a method of using the securementdevice of FIG. 1. As shown, the method can continue by removing a secondliner disposed over a portion of the bottom surface of the retainer. Theretainer may be secured to the patient before or after the medicalarticle is placed within the retainer.

FIGS. 20-22 are perspective views of a method of using the dressing ofFIG. 8. As shown, the method can begin by removing a first liner from aportion of a patient side surface of the dressing.

FIGS. 23-24 are perspective views of a method of using the dressing ofFIG. 8. As shown, the method can begin by removing a second liner from aportion of a patient side surface of the dressing.

FIGS. 25-26 are perspective views of a method of using the dressing ofFIG. 8. As shown, the method can continue by placing the dressing overthe insertion site and at least a portion of the medical article.

FIGS. 27-28 are perspective views of a securement device according toanother embodiment of the present invention.

FIG. 29 is another perspective view of the securement device of FIG. 1and shows a medical article placed in the retainer prior to a flap ofthe retainer being folded across the medical article.

FIG. 30 is an exploded view of the securement device of FIG. 27.

FIG. 31 is a plan view of the securement device of FIG. 27.

FIG. 32 is a top view of a method of using the securement device of FIG.27. As shown, the method can begin by removing a liner disposed over theretainer.

FIG. 33 is a top view of a method of using the securement device of FIG.27. As shown, the method can continue by placing a medical article inthe retainer.

FIGS. 34-36 are top views of a method of using the securement device ofFIG. 27. As shown, the method can continue by removing the linerscovering the lower surfaces of the anchor pad.

FIGS. 37-38 are top views of a method of using the securement device ofFIG. 27. As shown, the method can continue by removing the liner on theadhesive surface of the flap.

FIGS. 39-40 are top views of a method of using the securement device ofFIG. 27. As shown, the method can continue by folding the flap across anupper surface of the medical article.

FIG. 41 is a top view of the securement device of FIG. 27 with the flapin the closed position.

FIGS. 42-43 are top views of a method of using the securement device ofFIG. 27. As shown, the method can continue by placing a dressing overthe insertion site and at least a portion of the medical article.

FIGS. 44-45 are perspective views showing a securement system accordingto another embodiment of the present invention.

FIG. 46 is another perspective view of the securement device of FIG. 44and shows a medical article placed in the retainer.

FIG. 47 is an exploded view of the securement device of FIG. 44.

FIG. 48 is a perspective view of a method of using the securement deviceof FIG. 44. As shown, the method can begin by removing a liner disposedover the retainer.

FIG. 49 is a perspective view of a method of using the securement deviceof FIG. 44. As shown, the method can continue by removing a liner on alower surface of an anchor pad.

FIG. 50 is a top view of a method of using the securement device of FIG.44. As shown, the method can continue by placing a medical articlewithin the retainer.

FIGS. 51-53 are top views of a method of using the securement device ofFIG. 44. As shown, the method can continue by removing a liner from adressing and then folding the dressing over the medical article. Themedical article passes through a slot in the dressing.

FIGS. 54-55 are perspective views of a securement device according toanother embodiment of the present invention.

FIG. 56 is another perspective view of the securement device of FIG. 54and shows a medical article placed in the retainer before a portion ofthe anchor pad or flap is folded over the medical article.

FIG. 57 is an exploded view of the securement device of FIG. 54.

FIG. 58 is a top view of the securement device of FIG. 54 includingrelease liners on the lower surfaces of the device.

FIG. 59 is a top view of a method of using the securement device of FIG.54. As shown, the method can begin by removing a liner covering a lowersurface of the anchor pad.

FIG. 60 is a top view of a method of using the securement device of FIG.54. As shown, the method can continue by sliding the securement devicebetween the patient's skin and the medical article while guiding themedical article through a slot in the securement device.

FIG. 61 is a top view of a method of using the securement device of FIG.54. As shown, the method can continue by removing a second liner on alower surface of the anchor pad.

FIG. 62 is a perspective view of the securement device of FIG. 54secured to a patient.

FIGS. 63-65 are top views of a method of using the securement device ofFIG. 54. As shown, the method can continue by removing the liners fromthe flap.

FIGS. 66-67 are top views of a method of using the securement device ofFIG. 54. As shown, the method can continue by folding the flap over themedical article.

FIG. 68 is a rear perspective view of the securement device of FIG. 54showing the medical article secured in the securement device.

FIGS. 69-70 are perspective views of a securement device according toanother embodiment of the present invention.

FIG. 71 is another perspective view of the securement device of FIG. 69and shows a medical article placed on the retainer and with an integraldressing covering an insertion site.

FIG. 72 is an exploded view of the securement device of FIG. 69.

FIG. 73 is a top view of a securement device of FIG. 69 including aplurality of liners on the bottom surface of the device.

FIG. 74 is a top view of a method of using the securement device of FIG.69. As shown, the method can begin by removing a liner disposed over theretainer and folding over the anchor pad along a slot.

FIG. 75 is a top view of a method of using the securement device of FIG.69. As shown, the method can continue by removing a liner and slidingthe securement device between the patient's skin and the medical articlewhile guiding the medical article through the slot.

FIG. 76 is a top view of a method of using the securement device of FIG.69. As shown, the method can continue by removing liners from a bottomsurface of the dressing and the anchor pad and attaching them to thepatient.

FIGS. 77-78 are top views of a method of using the securement device ofFIG. 69. As shown, the method can continue by removing an additionalliner from a bottom surface of the dressing.

FIG. 79 is a top view of a securement device of FIG. 69 with thedressing secured over the medical article and the securement deviceattached to the patient.

FIGS. 80 and 83 are perspective views of support members.

FIGS. 81-82 are perspective views of a securement device with thesupport member of FIG. 80.

FIGS. 84-85 are perspective views of a securement device with thesupport member of FIG. 83.

DETAILED DESCRIPTION OF CERTAIN EMBODIMENTS

The following description and examples illustrate preferred embodimentsof the present securement device disclosed in the context of use withexemplary catheters. More specifically, the embodiments relate to astabilization device and related techniques that stabilize a medicalarticle in position on a patient. The embodiments of the securementdevice are illustrated with a catheter in use as part of a peripheralintravenous (“I.V.”) line.

The following description and the accompanying figures, which describeand show the preferred embodiments, are made to demonstrate severalpossible configurations that a securement device and/or system can taketo include various disclosed aspects and features. The illustratedembodiments are shown in use with a catheter having a spin nut. Theillustration of the securement device in this context is not intended tolimit the disclosed aspects and features to the specified embodiment orto usage only with the illustrated catheter. For example, the disclosedembodiments can be used with a connector fitting. The connector fittingmay include a spin nut or other outwardly extending feature. Those ofskill in the art will recognize that the disclosed aspects and featuresare not limited to any particular embodiment of a securement system, andsecurement systems, which include one or more of the inventive aspectsand features herein described, can be designed for use with a variety ofmedical articles.

It will be understood by those of skill in the art in view of thepresent disclosure that the securement device described can be used withother types of medical articles, including, but not limited to cathetersand catheter hubs of various design, either with or without connectorsor extension sets, such as central venous catheters, peripherallyinserted central catheters, hemodialysis catheters, Foley catheters, aswell as other designs of catheter hubs and catheter adaptors. Othermedical articles may include surgical drainage tubes, feeding tubes,chest tubes, nasogastric tubes, rectal drains, external ventriculardrains, chest tubes; any other sort of fluid supply or medical lines,connector fittings, and scopes, as well as electrical wires or cablesconnected to external or implanted electronic devices or sensors. Themedical articles can be a single medical article or a combination ofmedical articles.

The securement device described herein is especially adapted to arrestat least transverse movement of a catheter. The securement device holdsmedical articles against the patient and protects an area in proximityto an insertion site. The securement device accomplishes this withoutmeaningfully impairing (i.e., substantially occluding) fluid flowthrough a lumen of the medical article or impairing insertion of themedical article. In some embodiments, retention mechanisms to accomplishthis include a retainer having a recess, flap, straps, anchor pads,and/or dressings. For example, the recess, flap, straps, anchor pads,and or dressings may be coated with an adhesive. The flap or strap maybe integral to the securement device and fold over and secure a medicalarticle placed in the retainer. In other embodiments, the securementdevice may include an integrated dressing or portion of the anchor padconfigured to cover the insertion site. The integrated dressing/anchorpad may fold over another portion of the anchor pad/retainer so that themedical article is disposed therebetween.

In general, the securement may be attached to a patient and a medicalarticle may be placed at least partially within the securement. Thesecurement may include a recess. The recess may be formed by one or moreupwardly extending walls. The upwardly extending walls may be shaped toinclude one or more abutment surfaces. The abutment surfaces may inhibitand/or prevent movement of a medical article placed in the securement inat least one direction. The upwardly extending walls may include anadhesive on one or more surfaces. In some embodiments, at least aportion of the top surfaces of the upwardly extending walls forming therecess are coated with an adhesive. A dressing may be configured tocover an insertion site, the securement device, and at least a portionof the medical article. The medical article may be disposed between thesecurement and the dressing. In some embodiments, the dressing may beintegral with the securement.

To assist in the description of these components of the securementsystem, the following coordinate terms are used (see, e.g., FIGS. 7, 25,27, 46, 56, and 71). A “longitudinal axis” is generally parallel to aportion of the catheter hub or other medical article retained by thesecurement system, as well as parallel to the axis of the recess of theretainer, through which the medical article extends. A “lateral axis” isnormal to the longitudinal axis. A “transverse axis” extends normal toboth the longitudinal and lateral axes.

In addition, as used herein, “the longitudinal direction” refers to adirection substantially parallel to the longitudinal axis; “the lateraldirection” refers to a direction substantially parallel to the lateralaxis; and “the transverse direction” refers to a direction substantiallyparallel to the transverse axis. The term “axial” as used herein refersto the axis of the channel, recess, or hub, and therefore issubstantially synonymous with the term “longitudinal” as used herein.Also, the terms “proximal” and “distal,” which are used to describe thepresent securement system, are used consistently with the description ofthe exemplary applications (i.e., the illustrative examples of the useapplications). Thus, proximal and distal are used in reference to thecenter of the patient's body.

The terms “upper,” “lower,” “top,” “bottom,” “underside,” “upperside”and the like, which also are used to describe the present securementsystem, are used in reference to the illustrated orientation of theembodiment. For example, the term “upperside” is used to describe theportion of the retainer that is located above a lateral axis that passesthrough the axis of the recess in the retainer. The term “underside” isused to describe the portion of the retainer that is located below alateral axis that passes through the axis of the recess in the retainer.Brief introductions to some of the features, which are common to thedescribed embodiments of the securement systems, are now described.

Various aspects will now be described with reference to specific formsor embodiments selected for purposes of illustration. It will beappreciated that the spirit and scope of the securement system disclosedherein is not limited to the selected forms. Moreover, it is to be notedthat the figures provided herein are not drawn to any particularproportion or scale, and that many variations can be made to theillustrated embodiments. Brief introductions to some of the features,which are common to the described embodiments of the securement systems,are now described.

The preferred embodiments advantageously provide a medical linesecurement system for securing a medical article to a patient. Themedical article may have an elongated body. The elongated bodycooperates with a retainer to arrest movement of the medical article inlongitudinal, lateral, and transverse directions when placed within theretainer. The retainer may include a recess. The recess may be sized andshaped to receive a portion of a medical article, for example, a spinnut. The recess may provide one or more abutment surfaces that can limitmovement in the longitudinal and/or lateral direction. In someembodiments, the bottom surface of the recess includes an adhesive. Theadhesive can limit the longitudinal, lateral, and transverse movement ofa medical article placed within the recess of the retainer. The retainermay be supported by one or more anchor pads. The anchor pads may includean adhesive to attach the anchor pads to the skin of a patient. Aflap/strap coupled to the anchor pad and/or retainer may be folded overthe retainer further securing a medical article placed in the retainer.

The medical article may include a cannula. The cannula may be insertedinto a patient. This insertion site may be further covered by adressing. The dressing may further limit the movement of the medicalarticle. The dressing may also protect the insertion site from moistureand/or infection. In some embodiments, the dressing is integrated orcoupled to the retainer and/or anchor pad. In some embodiments, thesecurement systems disclosed herein can be attached to a patient after amedical line, for example a peripheral I.V. line, has been introduced tothe patient.

To facilitate a complete understanding of the embodiments, the remainderof the detailed description describes the securement systems withreference to the figures, wherein like elements among the embodimentsare referenced with like numerals throughout the following description.

With reference now to FIGS. 1-2 an embodiment of a securement device 100includes an anchor pad 104 and a retainer 101. The anchor pad 104 canhave a lower surface 106 which may adhere to the skin of a patient andan upper layer 105. The upper layer 105 of the anchor pad 104 isconfigured to support at least the retainer 101. In combination, thelower surface 106, upper layer 105, and possibly one or moreintermediate layers may comprise a laminate structure. A suitablelaminate that comprises a foam or woven material with an adhesive layeris commercially available. The anchor pad 104 may be configured as aflexible structure configured to conform to the surface of a patient'sskin. In some embodiments, at least a portion of a lower surface 106 ofthe anchor pad 104 includes an adhesive.

The upper layer 105 of the anchor pad 104 may comprise a foam (e.g.,closed-cell polyethylene foam) or woven material (e.g., tricot) layer ornon-woven material. A surface of the foam or woven material layerconstitutes the upper layer of the anchor pad 104. In the alternative,the upper layer 105 may comprise an upper paper or other nonwoven clothlayer, and an inner foam layer may be placed between the upper layer anda lower adhesive surface. In some embodiments, the anchor pad includesan anti-microbial additive. The anchor pad and retainer may protect apatient's skin from irritation caused by the medical device rubbingagainst the skin.

The anchor pad 104 is configured to be secured to a patient's skin. Theadhesive on the lower surface 106 of the anchor pad 104 may be amedical-grade adhesive and can be either diaphoretic or nondiaphoretic,depending upon the particular application. The lower adhesive surfacemay have additional types of medical adhesives laminated thereto such asa silicone adhesive. In some embodiments, the lower adhesive layercomprises an anti-bacterial or anti-microbial material. For example, thelower adhesive layer may comprise one or more oligodynamic metal saltsor oxides, or a combination of salts and oxides. In some embodiments,the lower adhesive layer comprises a silver material, for example asilver salt, colloid, or complex. The adhesive surface may be a solidlayer or may be configured as an intermittent layer such as in a patternof spots or strips. The lower adhesive surface can be applied to theanchor pad 104 during manufacture, and may be further covered with aliner as described below. Alternatively, it is possible to apply adouble-sided adhesive tape to the upper layer before application.

In the embodiment shown in FIG. 1, the anchor pad 104 includes tworemovable liners 135 and 136 on a lower surface 106 of the anchor pad104. The removable liners 135 and 136 may cover the lower adhesivesurface before use. The liners may resist tearing and be divided into aplurality of pieces to assist removal of the liners and ease attachmentof the anchor pad 104 to a patient's skin. The liners 135 and 136 may bedivided into two adjacent pieces. The liners 135 and 136 may be made ofa paper, plastic, polyester, or similar material. For example, theliners 135 and 136 may comprise a material made of polycoated,siliconized paper, or another suitable material such as high densitypolyethylene, polypropylene, polyolefin, or silicon coated paper.

As illustrated in FIGS. 1-2, the release liners 135 and 136 include tabs130 that extend beyond the edge of the anchor pad 104 to allow a medicalprovider to easily grip the release liners 135 and 136 and remove themfrom the anchor pad 104. The tabs 130 may be located at any edge of theanchor pad 104 and may be any suitable size or shape. As shown in FIGS.1-2 a portion of the release liner 136 may extend over a portion of therelease liner 135 at an interface 133 between the release liners 135 and136.

Continuing with FIGS. 1-2, a liner 120 may cover an adhesive surface ofthe retainer 101. The adhesive surface can be configured to adhere toportions of a dressing and/or portions of the medical article. The linermay cover the entire top surface of the retainer 101 or may only coverthe adhesive portions of the retainer 101. As illustrated in FIG. 1, theliner 120 is sized to cover the entire retainer 101 and to also extendbeyond the outer perimeter of the retainer 101. In this way, a portionof the liner 120 can form a pull tab 125. The pull tab 125 can allow thehealthcare provider to easily grip the liner 120 and remove the liner120 from the retainer 101. The liner 120 may be prepared such that theliner 120 maintains the covered surface of the retainer 101 in asterilized state. In some embodiments, the liner 120 has a longerdimension than the retainer 101 which insures the liner 120 is alwayscantilevered beyond the top edge of retainer 101 to create a gripingsurface for the user to remove the liner 120.

Turning to FIGS. 3-4, the retainer 101 is configured to receive andsecure at least a portion of a medical article. In the illustratedembodiment of FIGS. 3-4, the retainer 101 includes a top surface 102 anda recess 108 shaped to receive at least a portion of a medical article.The recess 108 also includes a channel 114 extending through theproximal side of the retainer 101. The channel 114 may be shaped toreceive at least a portion of the medical article. As shown, the channelmay have a lateral width that is less than the lateral width of therecess. The retainer 101 may also include proximal abutments 110 whichextend at least partially in a direction towards the channel 114. Theproximal abutments 110 may be shaped to contact at least a portion ofthe medical article and prevent movement of the medical article placedwithin the recess and/or channel in at least the proximal direction. Insome embodiments, the proximal abutments are disposed between the recess108 and the channel 114.

The recess may also include a distal abutment 111. The distal abutment111 may be formed by one or more walls extending upward from the topsurface of the anchor pad 104. The distal abutment 111 may be shaped tocontact at least a portion of the medical article and prevent movementof the medical article placed within the recess 108 and/or channel in atleast the distal direction.

The recess 108, channel 114, proximal abutments 110, and/or distalabutments 111 may be sized and shaped to fit any appropriate medicalarticle or portion thereof. In some embodiments, the recess 108, channel114, proximal abutments 110, and/or distal abutments 111 are sized andshaped to accept more than one type and/or more than one sized portionof a medical article. In this way, the securement system disclosedherein can be used with multiple medical articles. Multiple varieties ofspin nuts are used in the medical industry and may vary depending onapplication, geographic location, and/or supplier. Such spin nuts varyin size, shape, and/or dimension. Thus, the securement systems disclosedherein can advantageously provide a retainer configured to secure morethan one spin nut embodiment. For example, the recess 108, channel 114,proximal abutments 110, and/or distal abutments 111 may be sized andshaped such that when a first spin nut is inserted within the recess108, a proximal facing surface of the first spin nut is placed intocontact with a distal facing surface of the proximal abutment while adistal facing surface of the first spin nut does not contact a proximalfacing surface of the distal abutment. When a second, differently sizedand/or shaped spin nut is inserted within the same recess 108, aproximal facing surface of the second spin nut is placed into contactwith a distal facing surface of the proximal abutment while a distalfacing surface of the second spin nut is also placed into contact with aproximal facing surface of a distal abutment. In this way, one or moresurfaces of the spin nut may abut against one or more abutment surfacesof the retainer 101 depending on the size and/or shape of the spin nutthat is being secured. Accordingly, depending on, for example, thelength of the channel and the length of the spin nut, a gap or space mayexist in front of or behind a spin nut when the spin nut is insertedinto the retainer 101. In some embodiments, the recess 108 and channel114 are sized and shaped to approximately equal the size and shape of aparticular spin nut such that the spin nut snugly fits within the recess108 and channel 114.

In some embodiments, at least a portion of an interior surface of therecess 108 and/or channel 114 includes an adhesive. For example, anadhesive may be disposed on at least a portion of the lower surface ofthe recess 108 and/or channel 114 and/or on at least a portion of theinterior walls that form the recess 108 and/or channel 114. Othersurfaces of the retainer 101 may also include an adhesive. For example,in some embodiments, at least a portion of the top surfaces 102 of theupwardly extending walls that form the recess 108 include an adhesive.The adhesive may be similar to the adhesives described in connectionwith the anchor pad 104. The adhesive can adhere to one or more surfacesof a medical article placed within the retainer 101 so as to furtherlimit movement of the medical article. The retainer 101 may comprisevarious materials, for example, one or more elastomers. In someembodiments, the retainer 101 comprises a material configured to allowfor easy removal of occlusive wrapping and/or bandages.

FIG. 5 is an exploded view of the securement device of FIG. 1. The liner120 may be disposed on an upper surface 102 of the retainer 101. Theupper surface 102 of the retainer 101 may include an adhesive. Theadhesive may be configured to arrest movement of a medical article thatis placed into contact with the upper surface 102 of the retainer 101.In some embodiments, the upper surface 102 of the retainer 101 includesan adhesive such that the medical device may be stabilized on theretainer 101 allowing a user to let go of the medical device and usetheir hand to complete the installation. The retainer 101 and liner 120may be disposed on the anchor pad 104. At least a portion of the bottomsurface 106 of the anchor pad 104 may include an adhesive. Removableliners 135 and 136 may be disposed on the bottom surface 106 of theanchor pad 104 to cover the adhesive surface. The liners 135 and 136 maybe removed and the anchor pad 104 may be secured to the skin of apatient.

Turning to FIG. 6, a plan view of the retainer 101 and anchor pad 104 isshown. The retainer 101 includes a recess 108, a channel 114, proximalabutments 110, and distal abutment 111. The recess 108 may be anysuitable size and shape. As shown the recess 108 has a width that islarger than the width of the channel 114 extending in the proximaldirection from the recess 108. The difference in widths can formabutments 110. In other words, abutments 110 can extend into a proximalportion of the recess 108 to form a channel 114 that is narrower inwidth than the recess 108. In this way, the retainer 101 may receive atleast a portion of a medical article in at least a portion of thechannel 114 and/or in at least a portion of the recess 108. In addition,at least a portion of a proximal facing surface of the medical articlemay abut against a distal facing surface of the abutments 110. In thisway, the abutments 110 can prevent movement, at least in the proximaldirection, of a medical article placed within the retainer 101 whiledistal abutment 111 may prevent movement at least in the distaldirection. In some embodiments, the width of the recess 108 is about 7mm while the width of the channel 114 is about 4 mm.

As shown in FIG. 7, a medical article 200 may be placed within theretainer 101. The medical article can include a catheter 210 and acatheter hub 230 connected to an extension set 220. Catheter hubs aregenerally known to those skilled in the art. The catheter hub 230 shownin FIG. 7 has a proximal body 232 and a distal body 212. However,different catheter hubs may include more or less bodily sections havingvarious different shapes and sizes, all of which may be used with theretainer or other embodiments of the retainer described herein. Theextension set 220 illustrated in FIG. 7 includes a spin nut 244connected to a connector 225 that is coupled to a medical tube 222. Incertain embodiments, the catheter hub 230 comprises an integral one-wayvalve. In some embodiments, the retainer 101 is configured to suspendthe medical article 200 above the skin of a patient to allow for acatheter to be inserted into a patient's skin at an angle relative tothe skin of the patient, for example, at an angle of 7 degrees. Forexample, as shown in FIG. 7, the retainer 101 may be sized and shapedsuch that a back portion of a medical article is supported by a distalportion of the retainer 101. In some embodiments, the distal abutment111 may both suspend a distal portion of the medical article relative toa proximal portion of the medical article and prevent movement of themedical article in at least the distal direction by abutting against adistal facing surface of the medical article.

In the embodiment shown in FIG. 7, the recess 108 is shaped to receive aportion of the spin nut 244 and the channel 114 is shaped to receive aportion of the distal body 212 of the catheter hub 230. In this way, theproximal surface of the spin nut 244 can abut against a distal surfaceof the abutments 110. In other words, a proximal surface of the spin nut244 may abut against a distal surface of the retainer 101 so as toprevent movement of the catheter 200 in the proximal direction towardsthe patient.

The recess 108 and/or channel 114 may be shaped to receive differentportions of the medical article 200. For example, in some embodiments,the channel 114 and recess 108 are shaped to receive the connector 225.In this embodiment, the distal surface of the abutments 110 may contacta proximal facing surface of the connector 225 to prevent movement ofthe catheter 200 in the proximal direction. In this way, the spin nut244 is not secured by the retainer 101 and thus, the spin nut 244 can berotated to release the extension set 220 from the catheter hub 230 whilethe catheter hub 230 remains secured to the patient.

Turning to FIGS. 8-9, a dressing 400 that may be used with thesecurement device described above is shown. The dressing 400 comprisesan occlusive layer 418, a lower surface that is at least partiallycovered by an adhesive and two release liners 435 and 436 covering thelower surface of the dressing 400. The adhesive is configured to adhereto the skin of a patient and/or to portions of the anchor pads,retainer, and/or medical article. The dressing 400 includes an insertionwindow 426 and a retainer window 425. The dressing also includes achannel 450 and an opening 455 shaped to receive the medical tubing 222.As illustrated, the release liners 435 and 436 project out from thelower surface of the dressing and form pull tabs 437 and 439.

The release liners 435 and 436 may cover adhesive disposed on the lowersurface of the dressing 400. The release liners 435 and 436 may coverthe entire lower surface of the dressing or may only cover the adhesivesurfaces. The release liners 435 and 436 may include an anti-microbialor anti-bacterial material or coating, and/or have silver particlesdispersed throughout. The dressing 400 and release liners 435 and 436may be prepared such that the release liners 435 and 436 maintain acovered surface of the occlusive layer in a sterilized state. In someembodiments, only one release liner is used.

In some embodiments, the adhesive is included on a bottom surface of thedressing 400 at least around the perimeter of the insertion window 426and around the perimeter of the retainer window 425. In someembodiments, the adhesive covers the entire bottom surface of thedressing 400 except for the areas formed by the insertion window 426 andthe retainer window 425. In some embodiments, the adhesive on the bottomsurface of the dressing 400 is disposed such that the dressing 400 willnot adhere at the point of insertion. In this way, the likelihood ofaggravating or excoriating the insertion site or skin around theinsertion site and/or introducing contaminants and/or liquid near orinto the point of insertion may be reduced. In addition, the adhesive onthe bottom surface of the dressing 400 may be disposed such that theadhesive layer will not adhere or stick to the catheter and/or thecatheter hub. In this way, sticky residues and buildup on the catheterand catheter hub may be reduced or avoided. In other embodiments, theadhesive covers the entire bottom surface of the dressing 400 includingthe insertion window 426 and the retainer window 425.

As described above, the dressing 400 comprises a channel 450 and anopening 455. The channel 450 and opening 455 allow for the dressing tobe applied over a medical article. The dressing 400 may be configured toprovide a waterproof seal around an insertion site when applied to theskin of a patient over a catheter and/or catheter hub. In someembodiments, the dressing 400 is still breathable while the waterproofseal is created. In some embodiments, the dressing 400 is configuredsimilar to the anchor pad 104.

In some embodiments, the dressing 400 comprises a hemostatic dressing.In such embodiments, securing the dressing 400 over an insertion site orother wound may inhibit blood from flowing from the site. For example,the dressing 400 may comprise or be coated with a hemostatic orantihemorrhagic agent such as chitosan or other polysaccharide, acollagen like microfibrillar hemostat, anhydrous aluminum sulfate,potassium alum, titanium dioxide, a gelatin, or a solution of thrombin.In some embodiments, a small thin pad having hemostasis andanti-microbial properties is also provided. Such a pad may be configuredto surround the catheter and/or cover the insertion site. In someembodiments, an anti-microbial/hemostasis pad is integral to theretainer 101 or anchor pad 104 to improve ease of placement of the pad.In some embodiments, the pad is made of a material known as HemCon®. Insome embodiments, the dressing includes an anti-microbial additive.

FIG. 10 is an exploded view of the dressing 400. As shown, an occlusivelayer 418 may be disposed on the top surface 408 of the dressing 400.The bottom surface 406 of the dressing 400 may be at least partiallycovered by an adhesive. Release liners 435 and 436 may be disposed onthe bottom surface 406 of the dressing 400. As shown, the occlusivelayer 418, top surface 408, and release liner 435 of dressing 400,include a channel and an opening. In some embodiments, the bottomsurface 419 of the occlusive layer 418 is at least partially covered byan adhesive. In addition, release liner 435 may include a fold oversection 439 which contacts a portion 437 of the release liner 436. Inthis way, a pull tab 439 is covered completely by release liner 436.Thus, a healthcare provider is encouraged to first grip the portion 437of the release liner 436 to encourage proper placement technique. Afterfront or top of dressing 400 is attached to the skin then the healthcareprovider can grip the fold over section 439 to remove release liner 435.

The occlusive layer 418 may be configured to be waterproof or otherwiseimpermeable to liquids and in some embodiments also restricts the flowof air. In other embodiments, the occlusive layer 418 may be configuredto be breathable, allowing air and/or moisture near an insertion sitethrough to the other side of the occlusive layer 418 and away from theinsertion site, while keeping at least external moisture on the otherside of the occlusive layer 418 away from the insertion site. In someembodiments, the occlusive layer 418 is impermeable to viruses andbacteria, and may comprise or be coated with an anti-bacterial oranti-microbial material. In some embodiments, the occlusive layer 418comprises or is coated with a waxy material. In some embodiments, theocclusive layer 418 comprises a film which may or may not betransparent.

Selection of a transparent film or semi-transparent film for use as theocclusive layer 418 may allow a medical provider to see the insertionsite through the insertion window in the dressing. In this way,potential infections or inflammation may be visualized through thetransparent film. A transparent film or semi-transparent film for use asthe occlusive layer 418 may also allow a medical provider to see anyadministered catheter to ensure that a fluid connection is maintained.

In some embodiments, the occlusive layer 418 is absorbent. In someembodiments, the occlusive layer 418 comprises an absorbent acrylic, analginate, foam, a hydrocolloid, and/or a hydrogel material, and/or maycomprise a silver material, for example a silver salt, colloid, orcomplex. In one embodiment, one or more oligodynamic metal salts oroxides, or a combination of salts and oxides are used in or on theocclusive layer 418 as an antimicrobial agent. In some embodiments, theocclusive layer 418 is configured similar to the upper layer of theanchor pad 104.

In FIG. 11, a plan view of the dressing 400 is shown. As shown, thechannel 450 extends from the distal end of the dressing and terminatesat opening 455. In certain embodiments, the opening 455 is generallycircular in shape and includes a diameter greater than the width of thechannel 450. In this way, medical tubing may slide through the channel450 and rest within the opening 455. Thus, the dressing may be moreeasily placed over a medical article. The dressing 400 also comprisesnotches or indentations 458 in the sides of the dressing near the distalend. These notches 458 may locate perforation 428. The perforation 428may allow for a distal portion of the dressing to be removed easily fromthe remainder of the dressing.

In operation, a method of using the securement device and dressingdescribed above and a process for coupling a medical article to apatient can begin by removing the liner 120 covering the retainer 101 asillustrated in FIGS. 12A and 13-14. The liner 120 may cover one or moreadhesive surfaces of the retainer 101. In some embodiments, the entireupper surface 102 of the retainer 101 is coated with an adhesive. Asshown, the liners 135 and 136 attached to a surface of the anchor pad104 may include tabs 130 having one or more arrows that point toward theinsertion site such that a medical provider can properly orient thesecurement device.

As shown in FIGS. 12A-D, the liner tabs 130 may include numbering toindicate the order in which the liners should be removed from thesecurement device, as well as a message, for example, “Remove” toindicate that the liners are to be removed prior to use of thesecurement device. FIG. 12A shows one embodiment with pull tab 112 ofliner 120 including a “1” and pull tab 130 of liners 135 and 136including a “2” inside of an arrow to distinguish from pull tab 112. Asdiscussed above, the arrows may be positioned such that they indicate tothe medical provider the proper orientation of the securement device.FIG. 12B shows one embodiment of a liner 121 including pull tab 113 withthe number “1” on a solid color strip, for example black, with themessage 115 “Remove” encircled repeated across a visible surface of theliner. The lines forming the encircled areas, as well as the text in themessage 115 could be of the same color, which in one embodiment wouldmatch the solid color strip of the pull tab 113. FIG. 12C shows oneembodiment of a liner 137 that covers one portion of a lower surface ofthe anchor pad, and FIG. 12D shows one embodiment of a liner 138 thatcovers another portion of a lower surface of the anchor pad. Both liners137 and 138 may have the same solid color strip for pull tab 13 9, forexample, green, and include the message 115 “Remove” encircled repeatedacross a visible surface of the liner. In one embodiment the liners 137and 138 have a color scheme (e.g., solid color strip for pull tab, linesand text) the same as one another, and in another embodiment the colorschemes are different. In one embodiment, the color scheme of liners 137and 138 (whether different or the same) is different from the colorscheme of liner 121 to further differentiate the liners from oneanother.

The process can continue by removing the liners covering the loweradhesive surface of the anchor pad 104 and placing a medical articlewithin the retainer 101 as shown in FIGS. 15-19. As shown in FIG. 16,the liners covering the lower adhesive surface may comprise two liners135 and 136 that cover about one half of the lower adhesive surface. Theliners may fold back from the interface of the two liners 133 and extendout from the lower adhesive surface to form pull tabs 130. In this way,it is less likely that a medical provider will contact the loweradhesive surface with their hands and compromise the sterility of thelower adhesive surface. In some embodiments, the medical provider grabsone tab with each hand and partially removes the liners. The medicalprovider then places the anchor pad on the patient by moving the anchorpad towards the patient's skin while pulling the tabs to completelyremove the liners.

In the illustrated embodiment of FIG. 17, the securement device is slidunder a medical article 200 and one liner 135 is removed. The medicalarticle includes a spin nut 244. The spin nut 244 is at least partiallydisposed within the recess 108 and the channel formed in the retainer101. In certain embodiments, a proximal surface of the spin nut 244 isin contact with a distal surface of the retainer 101. Downward pressurecan be applied to the spin nut 244 such that a bottom surface of thespin nut 244 is pressed into contact with a bottom surface of therecess. Adhesive disposed on the upper surface 102 of the retainer 101and/or within the recess may further secure the medical article to theretainer 101 and prevent the medical article from moving in anydirection with respect to the retainer.

The process can continue by removing the second liner 136 covering thelower adhesive surface 106 of the anchor pad 104 as shown in FIGS.18-19. In this way, the anchor pad 104 is secured to the patient's skin.The removal of the liners and insertion of the medical article withinthe retainer may be done in any order. In some embodiments, both linersare removed at substantially the same time. In addition, the medicalarticle may be placed within the retainer either before or after themedical article is inserted into the patient. The securement device maybe attached to the patient either before or after the medical device isat least partially inserted into the patient.

In some embodiments, the process of securing the medical article to thepatient may continue by a obtaining an adhesive dressing, removing thedressing's liners, and placing the dressing over the securement deviceand insertion site as shown in FIGS. 20-26. FIG. 20 shows a topperspective view of the dressing 400 and FIG. 21 shows a bottomperspective view of the dressing 400. A medical provide may grab aportion 437 of the liner 436 that extends over the fold over section 439of liner 435. In some embodiments, the medical provider may grab theportion 437 of liner 436 and the fold over section 439 of liner 435 atthe same time. However, as shown in FIG. 22, liner 436 may be removedfirst to reveal a transparent or partially transparent insertion window426, a transparent or partially transparent retainer window 425, and anadhesive surface 406. In some embodiments, a portion of 438 of liner 436covers at least a portion of the retainer window 425. As such, whenliner 436 is removed during placement, the medical practitioner can seethrough at least a portion of the transparent retainer window 425 toview the medical device and assist in proper placement of the dressing.Release liner 435 may then be removed as shown in FIGS. 23-24.

After the liners are at least partially removed from the dressing 400,the dressing can be placed over the insertion site and adhered to thepatient with a suitable adhesive surface 406 on the underside of thedressing 400 as shown in FIGS. 25-26. In some embodiments, the dressingis configured to be waterproof or otherwise impermeable to liquids andin some embodiments also restricts the flow of air. In otherembodiments, the dressing may be configured to be breathable, allowingair and/or moisture near an insertion site through to the other side ofthe dressing and away from the insertion site, while keeping at leastexternal moisture on the other side of the dressing away from theinsertion site. In some embodiments, the dressing is impermeable toviruses and bacteria, and may comprise or be coated with ananti-bacterial or anti-microbial material. In some embodiments, thedressing comprises or is coated with a waxy material. The combination ofthe dressing covering the medical device and the anchor pad and retainerlocated underneath the medical device can create a 360 degree holding ofthe medical device.

As shown in FIG. 26, the insertion site and at least a portion of themedical article can be seen through the windows 425 and 426. Inaddition, the medical line 222 may pass through the channel 450 in thedistal side of the dressing to rest within opening 455. Thus, a portionof the dressing may close around the medical line 222 at the distal endof the dressing. In this way, fluids, foods, and/or other contaminantsare prevented from entering the insertion site.

To remove a distal portion dressing and release the medical tube 222, amedical provider may tear along the perforation 428 located by notches458 and remove the distal portion of the dressing. In some embodimentsthe securement device, dressing, and/or tape is included in a kit. Thekit may further include instructions for using the kit components.

With reference now to FIGS. 27-28, an embodiment of a securement device500 includes an anchor pad 104, a retainer 102, and a flap 510. Theanchor pad 104 is configured to be secured to a patient's skin. In someembodiments, at least a portion of a lower surface 106 of the anchor pad104 includes an adhesive. The retainer 102 is configured to receive andsecure at least a portion of a medical article. In the illustratedembodiment of FIGS. 27-28, the retainer 102 includes a recess 108 shapedto receive at least a portion of the medical article. In someembodiments, at least a portion of the upper surface of the retainer 108includes an adhesive. The flap 510 is configured to fold over theretainer 102.

With reference now to the flap 510, it can be seen in FIG. 27 that theflap 510 is attached to and/or integrated with the securement device500. The flap 510 is configured to fold, bend, or rotate down over theretainer 102. The flap 510 and the anchor pad 104 and/or the retainer102 may be formed as an integral, single piece. Alternatively, the flap510 and the anchor pad 104 may be formed separately and then attachedtogether. In this case, the flap 510 and the anchor pad 104 may beattached by any means or mechanism that allows the flap 510 to fold,bend, or rotate down over the retainer 102. Attachment means includeglue or adhesive, a weld of the materials, heat sealing, mechanicalfasteners such as staples or eyelets, or other such means of attachment.

A liner 513 may cover an adhesive surface of the flap 510. The adhesivesurface is configured to adhere to a medical article, portions of theretainer 102, portions of a medical article, and/or to portions of theupper surface of the anchor pad 104. The liner 513 may cover the entiresurface of the flap 510 or may only cover adhesive portions of the flap510. The flap 510 and liner 513 may be prepared such that the liner 513maintains a covered surface of the flap 510 in a sterilized state. Asillustrated in FIG. 28, the liner 513 includes a tab 512. The tab 512can allow the healthcare provider to easily grip a portion of the liner513 and pull the liner 513 away from the upper surface of the flap 510,thus removing the liner 513 and exposing an adhesive surface. The tab512 may be integral to the liner 513 and in some embodiments comprises afold over section of liner 513.

With reference now to the retainer 102, FIGS. 27-28 show a retainer thatincludes a recess 108. The recess 108 may be any suitable size andshape. As shown, the recess 108 is generally shaped as an elongatedtrapezoid. In this way, the longitudinally tapered walls of the recess108 can serve as an abutment surface for a portion of a medical articleplaced within the retainer 102. Turning briefly to FIG. 29, the proximalwall of the recess 108 may serve as an abutment surface as well. Inother words, a proximal surface of a spin nut 244 may abut against adistal surface of the retainer 102 so as to prevent movement of acatheter 200 in the proximal direction. In some embodiments, theretainer 102 is configured to suspend the spin nut 244 above the skin ofa patient to allow for the catheter 200 to be inserted into thepatient's skin at an angle relative to the skin of the patient, forexample, 7 degrees.

Returning to FIGS. 27-28, at least a portion on the lower surface of therecess 108 can include an adhesive. Other surfaces of the retainer 102may also include an adhesive. For example, in some embodiments, one ormore walls that form the recess 108 include an adhesive. An adhesive mayalso be included on the uppermost surface of the retainer 102. Theadhesive can adhere to one or more surfaces of a medical article 200placed within the retainer 102 so as to further limit movement of themedical article 200.

FIG. 30 is an exploded view of the securement device 500 of FIG. 29. Asshown, the retainer 102 may be disposed on a portion of the flap 510.However, in some embodiments, the retainer 102 is disposed on the anchorpad 104. A liner 514 may be disposed over the retainer 102. As shown,the liner 514 covers the upper surfaces of the upwardly extending wallsforming the recess 108. In this embodiment, the uppermost surfaces 515of the retainer 102 include an adhesive surface which may be covered bythe removable liner 514.

The flap 510 may include an adhesive surface 516 which may be covered byremovable liner 513. The flap 510 is configured to fold, bend, or rotatedown over the retainer 102. In this way, when closed, the underside ofthe flap in the closed position can adhere to one or more surfaces onthe anchor pad and/or retainer and/or medical article. The flap 510 mayrest on a portion of the anchor pad 104. In some embodiments, the flap510 is coupled to at least a portion of the anchor pad 104 and/or atleast a portion of the retainer 102. In some embodiments, at least aportion of an upper surface of the anchor pad on the side that isopposite to the flap 510 includes an adhesive surface. In this way, theadhesive on the upper surface of the anchor pad opposite to the flap 510can further secure the flap 510 when the flap is folded over theretainer 102.

The anchor pad 104 may include a lower adhesive layer 106 such that theanchor pad 104 may be secured to the skin of a patient when liners 520and 521 are removed. Liners 514, 520, and 521 may be similar to or thesame as the liners described above. As shown in FIG. 30, the liners 520and 521 may comprise two sections that are hingedly connected. At leasta portion of the liners 520 and 521 may be sized to extend out from theperimeter of the anchor pad forming pull tabs 525 and 526.

FIG. 31 shows a plan view of the securement device 500. As shown, therecess 108 in the retainer 102 is roughly trapezoidal in shape having anarrower width at the proximal end than the width at the distal end. Inthis way, various medical devices and/or spin nuts may be at leastpartially inserted within the retainer 102 as discussed above. In someembodiments, the side walls of the retainer running generally from thedistal end to the proximal end of the device may function as abutmentsurfaces. Thus, these side walls may abut against a proximal facing sideof a media article or portion thereof when the article is placed withinthe recess 108 to prevent movement of the article in at least theproximal direction.

In operation, a method of using the securement device 500 describedabove and a process for coupling a medical article to a patient canbegin by removing the liner 514 covering the uppermost surfaces of theretainer 102 as illustrated in FIG. 32. The process can continue byplacing a medical article 200 within the recess 108 of the retainer 102.As shown, the medical article 200 includes a spin nut 202. The retainer102 of the securement device can be positioned such that at least aportion of the spin nut 244 is above the retainer 102. As shown in FIG.33, downward pressure can be applied to the spin nut 244 such that thespin nut 244 can be moved at least partially into the recess 108 of theretainer 102 and in contact with at least one adhesive surface of theretainer 102.

The process can continue by removing the liners 520 and 521 covering thelower adhesive surface 106 of the anchor pad 104 as shown in FIGS.34-36. In this way, the anchor pad 104 is secured to the patient's skin.As shown in FIG. 34, the liner 520 may be removed by grabbing the pulltab 525 and pulling the liner 520 away from the lower surface of theanchor pad 104. Thus, as shown in FIG. 35, the right hand side of theanchor pad is secured to the patient's skin. Similarly, as shown in FIG.36, the liner 521 may be removed by grabbing the pull tab 526 andpulling the liner 521 away from the lower surface of the left hand sideof anchor pad 104. As illustrated in FIG. 36, a user may wish to holdthe flap 510 away from the anchor pad 104 in order to better access thepull tab 526. With the liners 520 and 521 removed from the loweradhesive surface 106 of the anchor pad 104, the anchor pad 104 issecured to the patient's skin.

Turning to FIGS. 37-38, the liner 513 on the top surface of the flap 510may be removed by grabbing the pull tab 512 and pulling the liner 513away from the top surface of the flap 510. In this way, the adhesivesurface 516 on the top side of the flap 510 is exposed. As illustratedin FIGS. 39-40, the flap 510 can be folded over the retainer 102 suchthat a portion of the adhesive surface 516 of the flap 510 covers thespin nut 244 and the retainer 102. The flap 510 may also come intocontact with a portion of the anchor pad 104. In this way, the flap 510further secures the medical article to the patient. FIG. 41 shows a topview of the securement device 500 with the flap 510 in the closedposition.

In some embodiments, the process of securing the medical article to thepatient may continue by obtaining a dressing 400 as shown in FIG. 42.After a liner is removed from the dressing 400 may be removed from thelower surface of the dressing 400, exposing an adhesive surface on thelower side of the dressing 400. The dressing 400 can then be placed overthe insertion site and adhered to the patient with a suitable adhesivesurface on the underside of the dressing as shown in FIGS. 42-43. Thedressing may include an occlusive layer 418 as described above. As shownin FIG. 43, in some embodiments, the outer perimeter 499 of the dressingmay be removed from the occlusive layer 418. In some embodiments, a kitincludes the securement device, dressing, and/or tape. The kit mayfurther include instructions for using the kit components.

Turning now to FIGS. 44-53, another embodiment of a securement device600 includes an integral dressing 618, a retainer 102, and an anchor pad104. The dressing 618 is integral and/or coupled to the anchor pad 104and the dressing 618 is configured to fold over the insertion site aswill be further explained below. As shown, the retainer 102 is coveredby liner 617 having a pull tab 616. The top facing side of the dressing618 is covered by a liner 625 b disposed over an adhesive surface of thedressing 618. The liner 625 b includes a fold over section forming pulltab 625 a. When the liner 625 b is removed, a medical article 200 thatmay include a spin nut 244, can be placed within the retainer 102 asshown in FIG. 46. The retainer 102 can include one or more adhesivesurfaces.

As illustrated, the retainer 102 may include a recess 108. The retainer102 may be disposed over an adhesive layer 612 such that the bottomsurface of the recess 108 in the retainer 102 includes an adhesivesurface. The adhesive layer 612 may also function to secure the retainerto the anchor pad 104. The adhesive layer 612 may be disposed on theanchor pad 104. Adhesive layer 614 may be disposed on the uppermostsurface of the retainer 102 and may be covered by the removable liner617.

Turning to the dressing 618, as shown in FIG. 47, the dressing 618 caninclude an adhesive layer 622, a pad 623, and an occlusive layer 418. Asshown in FIG. 47, the adhesive layer 622 can be disposed on the top sideof the pad 623 and the occlusive layer 418 may be disposed on theunderside of the pad 623. The adhesive layer 622 may cover all or aportion of the topside of the pad 623.

The dressing 618 can include an opening 626 configured such that amedical article can pass through the opening 626 when the dressing 618is folded over to cover the insertion site and the medical article. Thedressing 618 can also include a slot 636. The slot 636 can be sized andshaped such that a portion of the medical article can pass through theslot 636. The pad 623 can include a window 632. The window 632 can allowfor the insertion site to be observed without removing the dressing 618.The adhesive layer 620 may be covered by liner 625 b having a pull tab625 a. As shown, the liner 625 b is generally the same size and shape asthe pad 623 but does not include an opening or slot.

In operation, a method of using the securement device 600 and a processfor coupling a medical article to a patient can begin by rotating thedressing 618 away from the anchor pad 104 so as to unfold the securementdevice 600 as shown in FIGS. 44-45. A user may then grab pull tab 616and remove the liner 617 (as shown in FIG. 47) from the retainer, thusexposing the adhesive layer 614 as shown in FIG. 48.

The process can continue by removing the liner 608 covering the loweradhesive surface of the anchor pad 104 as shown in FIG. 49, thusexposing the adhesive layer. The process can continue by placing amedical article 200 having a spin nut 244 into the recess 108 of theretainer 102 as shown in FIG. 50 and placing the adhesive layer of theanchor pad on the patient's skin. Thus, the medical article 200 can beplaced into contact at least one adhesive surface of the retainer 102and the securement device is secured to the patient. Turning to FIG. 51,the process can continue by grabbing the pull tab 625 a on the dressingand removing the liner 625 b by pulling the pull tab 625 a away from thedressing 618. In this way, the adhesive layer 622 of the dressing 618 isexposed as shown in FIG. 52. As shown in FIG. 53, the dressing 618 canthen be folded over the anchor pad 104, retainer 102, medical article,and insertion site. In this way, the dressing 618 is secured to thepatient's skin.

Moving to FIGS. 54-68, another embodiment of a securement device 700includes a flap 708, a retainer 102, and an anchor pad 104. In certainembodiments, the flap 708 is a portion of the anchor pad 104. The anchorpad may include a folding line 789. In such an embodiment, the portionof the anchor pad which folds over the retainer 102 is the flap 708. Thefolded portion of the anchor pad attaches to another portion of theanchor pad. In this way a first portion of the anchor pad is adhered toa second portion of the anchor pad.

The retainer 102 includes a recess 108 and one or more adhesivesurfaces. The retainer 102 is supported the anchor pad 104. The anchorpad 104 is generally rectangular shaped and includes a generallycircular opening 710 having a slot 712. The slot 712 is configured toallow a portion of a medical article to pass through the slot 712 andinto the opening 710 of the anchor pad 104 as will be discussed below.At least a portion of the lower surface 106 of the anchor pad 104 caninclude an adhesive.

The flap 708 or portion of the anchor pad 104 is configured to move,rotate, and/or fold over another portion of the anchor pad 104. The flap708 includes a window 714. The window 714 is generally sized and shapedthe same as the opening 710 in the anchor pad 104. The window 714 in theflap 708 may be covered by a transparent or translucent film. The topside of the flap 708, as shown in FIGS. 54-55 may include an adhesivesurface 744. The adhesive surfaces of the retainer 102, anchor pad 104,and/or flap 708 may further be covered by one or more liners. Forexample, as shown in FIG. 57, a liner 799 may cover the adhesive surface716 of the retainer 102. As shown in FIG. 56, a medical article 200having a spin nut 244 may be placed in the recess 108 in the retainer102. The opening 710 in the anchor pad 104 generally surrounds thecatheter insertion site. The flap 708 may be folded over the anchor pad104 such that the retainer 102, anchor pad 104, and/or the medicalarticle 200 are contacted by the flap 708.

FIG. 57 is an exploded view of the securement device 700. An adhesivelayer 716 may be disposed on a top surface of the retainer 102. Theretainer 102 may be disposed on the anchor pad 104. The adhesive layeron the underside of the anchor pad may be covered by removable liners726 b and 727 b having folder over sections forming pull tabs 726 a and727 a. The flap 708 includes a film 718 disposed over the window 714. Anadhesive layer 744 may be disposed on the top side of the flap 708 suchthat when the flap 708 is folded over the medical article, the adhesivelayer 744 can adhere to the medical article securing the flap 708 in theclosed position. The adhesive layer 744 may be covered by removableliners 721 b and 722 b having folder over sections forming pull tabs 721a and 722 a.

In operation, a method of using the securement device 700 and a processfor coupling a medical article to a patient can begin by removing theliners 726 a and 727 b having pull tabs 726 a and 727 a from theunderside of the anchor pad 104 as shown in FIGS. 58-61. In general,each liner covers approximately half of the underside of the anchor pad104. More or less liners may be used in any number of configurations. Asshown, in FIG. 59, the left hand side liner 727 b and pull tab 727 a(i.e. the liner covering the underside of the slot side of the anchorpad 104) is removed exposing the adhesive layer on the underside of theanchor pad 104.

The process can continue by positioning the securement device 700 suchthat a medical article is passed through the slot 712 and into theopening 710 of the anchor pad 104 as shown in FIG. 60. The retainer 102of the securement device 700 can be positioned such that the spin nut244 of the medical article is positioned above the retainer 102 and madeto contact at least one adhesive surface of the retainer 102. The secondliner liner 726 b and pull tab 726 a can then be removed from theunderside of the anchor pad 104 as shown in FIG. 61. Thus, thesecurement device 700 is secured to a patient's skin. As shown in FIG.62, in some embodiments, the retainer 102 is configured to suspend thespin nut 244 above the skin of a patient at an angle relative to theskin of the patient, for example, 7 degrees.

The process continues in FIGS. 62-65 by removing the liners 721 b and722 b and pull tabs 721 a and 722 a from the flap 708 to expose theadhesive surface 744. The flap 708 is then folded over the anchor pad104, retainer 102, and medical article 200 as shown in FIGS. 66-68. Inthis way, the medical article is secured to the patient's skin.

Turing to FIGS. 69-79, another embodiment of a securement device 700includes a retainer 102 and an anchor pad 104. The illustratedembodiment of the retainer 102 does not include a recess as describedabove but rather at least a portion of the top surface of the retainer102 includes an adhesive 808. The retainer 102 is configured to secure amedical article at an angle. As shown, the top surface is at an angle θ.A variety of different angles θ can be used, ranging from 0 degrees to45 degrees or from 5 degrees to 25 degrees. For instance, for thesecurement of intravenous catheters, it is desirable for the angle ofincidence of the catheter to the skin of the patient to be between about7 degrees to about 15 degrees. For the securement of arterial catheters,it is desirable for the angle of incident of the catheter to the skin ofthe patient to be about 12.5 degrees. By angling the top surface of theretainer 102 at the desired angle, which will depend upon the particularsecurement application (e.g., securing an arterial catheter, anintravenous catheter, etc.), the proper angle of incidence for acatheter can be maintained.

As shown in FIGS. 69-71, the anchor pad 104 is shaped to include twowing portions 816 configured to support the retainer 102 and a loopportion 850 configured to generally surround the insertion site of themedical article and frame a film 812. The underside of the anchor pad104 may include an adhesive layer 106.

As shown in FIG. 71, a medical article 200 having a spin nut 244 may beplaced on the top surface of the retainer 102. The loop portion 850 ofthe anchor pad 104 generally surrounds the insertion site. The loopportion 850 of the anchor pad 104 frames a film 812. The anchor pad 104can also include a slot 814. The slot 814 can be sized and shaped suchthat a medical article can pass through the slot 814.

FIG. 72 is an exploded view of the securement device 800. Double sidedtape 808 may be disposed on a top surface of the retainer 102. Theretainer 102 may disposed on the anchor pad 104 in generally the centerof the winged portion 816 of the anchor pad 104. The underside of theanchor pad 104 may be covered by an adhesive layer 106. A portion of theunderside of the adhesive layer 106 may be covered by a film 810. Insome embodiments, at least the outer most portions or outside perimeterof the adhesive layer 106 is not covered by the film 810. In someembodiments, the underside 811 of the film 810 includes an adhesivelayer. Removable liner 809 may cover the adhesive surface 808 of theretainer 102. Removable liners 806, 807, and 822 can be disposed on theunderside of the anchor pad 104 and film 810. The removable liners 806,807, 809, and/or 822 may include fold over sections forming pull tabs asdiscussed above.

In operation, a method of using the securement device 800 and a processfor coupling a medical article to a patient can begin by folding overthe loop portion 850 of the anchor pad 104 away from the slot side ofthe anchor pad 104 and removing a release liner 808 covering the topadhesive surface of the retainer 102 as shown in FIG. 74

The process can continue by positioning the securement device 800 suchthat the retainer 102 is positioned below a portion of the medicalarticle 200 as shown in FIG. 75. The process continues as shown in FIG.76 by removing the release liner 822 covering the adhesive surface ofthe underside of the winged portion 816 of the anchor pad 104. Therelease liner 807 covering a about a half of the lower surface of theloop portion 850 of the anchor pad 104 can then be removed as well.Thus, the slot side of the loop portion 850 of the anchor pad 104 isadhered to the patient's skin as shown in FIG. 77. The second liner 806covering the remaining portion of the adhesive layer on the lowersurface of the anchor pad 104 and/or covering the film 810 is removed asshown in FIG. 78. The medical article is thus secured to the patient asshown in FIG. 79.

The securement devices described herein may include a support member tosupport portions of the medical article extending distal of theretainer, for example retainer 101, and/or distal of the recess in theretainer, for example recess 108. For instance, certain catheters mayhave longer lengths or be attached to extension tubing that isadvantageously supported by a support member. The support member may bemade of any suitable material, for example, foam or plastic, and in oneembodiment is formed from the same material as the retainer, for exampleretainer 101. The support member may be a separate component from thesecurement device or may be integral to the securement device, forexample as an extension of the retainer. The support member may includea section configured to attach to a catheter portion or extension tubeportion extending distal of the retainer, such as by friction fit (e.g.,snapping onto the catheter portion). The support member may be connectedto the securement device, for example at the distal end of the retainer,along a fold line or perforation line so that the support member can beeither connected to or separate from the retainer. In one embodiment,the support member may be connected to the dressing.

FIG. 80 illustrates one embodiment of a support member 900. The supportmember 900 has a front face 902, a rear face 904, and a channel 908extending from a top surface 906. The support member 900 has a thickness910. FIG. 81 illustrates one example of support member 900 in use with asecurement device including retainer 101. Catheter 290 is supported bythe securement device and includes portions in the channel 108. Catheterportions 292 and 294 extend beyond channel 108, and catheter portion 294is supported by support member 900. In FIG. 81, catheter portion 294 isshown resting in channel 908 but not entirely within the channel 908,and support member 900 is positioned distal of retainer 101 abutting arear portion thereof. Support member 900 can be a separate component,unattached or attached in some manner to the rear face of retainer 101(e.g., via adhesive), or can be integral to retainer 101 as an extensionthereof. FIG. 82 illustrates one example of support member 900 extendingfrom a top face of retainer 101. Again, support member 900 can be aseparate component, unattached or attached in some manner to the rearface of retainer 101 (e.g., via adhesive), or can be integral toretainer 101. In one embodiment, support member 900 in FIG. 81 can befolded along a fold line away from the top surface of the retainer whileremaining connected thereto. In the embodiment of FIG. 81, catheterportion 294 is shown entirely within channel 908, for example in afriction fit arrangement so that catheter 290 is releasably locked tosupport member 900.

FIG. 83 illustrates one embodiment of a support member 910. The supportmember 910 has a front face 912, a rear face 914 and a side face 916.The support member 910 is shown formed as a particular prism shape, butother geometric shapes are also contemplated, for example a rectangularprism, triangular prism, hexagonal prism, cylinder, etc. FIGS. 84-85illustrate different views of support member 910 associated withretainer 101 of a securement device. Catheter portion 292 is shownresting on an edge between surfaces of the support member 910. Supportmember 910 can be a separate component, unattached or attached in somemanner to the rear face of retainer 101 (e.g., via adhesive), or can beintegral to retainer 101 as an extension thereof. In FIGS. 84-85,support member 910 is shown attached to retainer 101 along fold line 920that permits support member 910 to be folded from a non-use position(not shown) to a use position in which the support member is angled withrespect to the retainer 101. In one embodiment, fold line 920 isperforated to facilitate separation of the support member 910 from theretainer. Although the support members 900 and 910 are shown coupled tothe retainer in FIGS. 81-82 and 84-85, it is also contemplated that thesupport members could be coupled to other aspects of the securementdevice, such as, for example, the anchor pad or dressing.

It is to be noted that the figures provided herein are not drawn to anyparticular proportion or scale, and that many variations can be made tothe illustrated embodiments. Those of skill in the art will recognizethat the disclosed aspects and features shown herein are not limited toany particular embodiment of a stabilization system, and stabilizationsystems that include one or more of the features herein described can bedesigned for use with a variety of medical articles.

The various embodiments of the securement devices and systems describedabove in accordance with the present invention thus provide a means tosecure a medical article a patient. The insertion site of a catheterattached to the connector fitting or extension set may be covered with adressing.

Of course, it is to be understood that not necessarily all objects oradvantages may be achieved in accordance with any particular embodimentof the invention. Thus, for example, those skilled in the art willrecognize that the invention may be embodied or carried out in a mannerthat achieves or optimizes one advantage or group of advantages astaught herein without necessarily achieving other objects or advantagesas may be taught or suggested herein.

Furthermore, the skilled artisan will recognize the interchangeabilityof various features from different embodiments. For example, thefeatures of the retainers disclosed in the various embodiments can beswitched between embodiments. In addition to the variations describedherein, other known equivalents for each feature can be mixed andmatched by one of ordinary skill in this art to construct stabilizationsystems and techniques in accordance with principles of the presentinvention.

Although this invention has been disclosed in the context of certainembodiments and examples, it will be understood by those skilled in theart that the present invention extends beyond the specifically disclosedembodiments to other alternative embodiments and/or uses of theinvention and obvious modifications and equivalents thereof. Thus, it isintended that the scope of the present invention herein disclosed shouldnot be limited by the particular disclosed embodiments described above.

What is claimed is:
 1. A securement system for a medical article,comprising: a stabilization device, including: an anchor pad; and aretainer having a proximal side, a distal side, and an upper side, theretainer including: a recess and a channel disposed within the retainer,the channel extending from the recess to the proximal side of theretainer, the channel and recess configured to receive a portion of themedical article therein; and a support member coupled to the distal sideof the retainer, the support member configured to support a portion ofthe medical article extending distally of the recess.
 2. The securementsystem according to claim 1, wherein the support member is separate fromthe retainer.
 3. The securement system according to claim 2, wherein thesupport member is coupled to the distal side of the retainer via anadhesive.
 4. The securement system according to claim 1, wherein thesupport member is integral with the retainer.
 5. The securement systemaccording to claim 4, wherein the support member extends from the upperside of the retainer.
 6. The securement system according to claim 1,wherein the support member is separable from the retainer via aperforation.
 7. The securement system according to claim 1, wherein thesupport member includes a channel configured to receive the portion ofthe medical article extending distally of the recess.
 8. The securementsystem according to claim 7, wherein the support member channel isconfigured to releasably lock the support member to the medical article.9. The securement system according to claim 1, wherein the supportmember is coupled to the retainer along a fold line, the support memberconfigured to fold from a non-use position to a use position.
 10. Thesecurement system according to claim 1, wherein the support member is inthe form of a prism shape.
 11. The securement system of claim 1, whereinthe retainer includes at least one adhesive surface.
 12. The securementsystem of claim 11, wherein the adhesive surface contacts at least aportion of the medical article.
 13. The securement system of claim 1,wherein the channel has a lateral width less than a lateral width of therecess.
 14. The securement system of claim 1, wherein the retainerincludes at least one abutment configured to contact a proximal facingsurface of the medical article.
 15. The securement system of claim 14,wherein the at least one abutment is disposed between the recess and thechannel.
 16. The securement system of claim 1, wherein the retainerfurther includes an abutment positioned distal from the channel, theabutment configured to contact a distal facing surface of the medicalarticle.
 17. The securement system of claim 1, further comprising adressing comprising a pad layer and a transparent film layer, the padhaving a first window so that the medical article is visible through thefirst window when the dressing is placed over the stabilization device.18. The securement system of claim 17, wherein the pad includes a secondwindow so that an insertion site of the medical article is visiblethrough the second window when the dressing is placed over thestabilization device.